labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler biocon pharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 400 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-063
Product ID 70377-063_f285cda1-e518-405e-9362-292ae2e14954
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209603
Listing Expiration 2027-12-31
Marketing Start 2024-12-02

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70377063
Hyphenated Format 70377-063

Supplemental Identifiers

RxCUI
896758 896762 896766 896983
UPC
0370377061134 0370377060120 0370377063121 0370377063114
UNII
1GEV3BAW9J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name labetalol hydrochloride (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number ANDA209603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70377-063-11)
  • 100 TABLET, FILM COATED in 1 BOTTLE (70377-063-12)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70377-063-13)
source: ndc

Packages (3)

70377-063-11 30 TABLET, FILM COATED in 1 BOTTLE (70377-063-11) 70377-063-12 100 TABLET, FILM COATED in 1 BOTTLE (70377-063-12) 70377-063-13 500 TABLET, FILM COATED in 1 BOTTLE (70377-063-13)

Ingredients (1)

labetalol hydrochloride (400 mg/1)

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f285cda1-e518-405e-9362-292ae2e14954", "openfda": {"upc": ["0370377061134", "0370377060120", "0370377063121", "0370377063114"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766", "896983"], "spl_set_id": ["27e4ab03-c17b-4268-912c-e45a5e8f8dd8"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70377-063-11)", "package_ndc": "70377-063-11", "marketing_start_date": "20250807"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70377-063-12)", "package_ndc": "70377-063-12", "marketing_start_date": "20241202"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70377-063-13)", "package_ndc": "70377-063-13", "marketing_start_date": "20241202"}], "brand_name": "Labetalol Hydrochloride", "product_id": "70377-063_f285cda1-e518-405e-9362-292ae2e14954", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70377-063", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA209603", "marketing_category": "ANDA", "marketing_start_date": "20241202", "listing_expiration_date": "20271231"}